FINELINE II EZ Sterox
Received Jul 30, 2026 · Event occurred Mar 24, 2014
Report 2124215-2026-41057 · MDR key 50090678
Device
Generic name
Implantable Lead
Manufacturer
Boston Scientific CorporationModel number
4469Catalog number
4469
Product problems
- Off-Label Use
- Material Integrity Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that when replacing the associated device related to this right atrial (RA) lead insulation nicks were noted for which a silicone repair kit was used to fix the observed anomaly. Subsequently the implant pocket was irrigated using an antibiotic solution. The procedure was then successfully completed. This RA lead remains in service. Other than the intervention no adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress. This report will be updated when product investigation is complete.